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Active, not recruiting Phase 1

A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors

NCT06544655 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2024-10-10
Last updated
2026-04-17

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

BMS-986484Nivolumab →Oxaliplatin →Capecitabine →Fluorouracil →Calcium folinate →

BMS-986484: Specified dose on specified days

Nivolumab: Specified dose on specified days

Oxaliplatin: Specified dose on specified days

Capecitabine: Specified dose on specified days

Fluorouracil: Specified dose on specified days

Calcium folinate: Specified dose on specified days

Study summary

The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN). * Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). * Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. Exclusion Criteria: * History of or with active interstitial lung disease or pulmonary fibrosis. * Active, known, or suspected autoimmune disease. * Serious uncontrolled medical disorders. * New onset, non-catheter-associated venous thromboembolism within the past 6 months. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Incidence of adverse events (AEs) — Up to approximately 2 years
  • Incidence of serious adverse events (SAEs) — Up to approximately 2 years
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria — Up to approximately 28 days
  • Incidence of AEs leading to discontinuation — Up to approximately 2 years
  • Incidence of AEs leading to death — Up to approximately 2 years

Trial sites (9)

FacilityCityRegionStatus
Local Institution - 0003 Tucson Arizona
Local Institution - 0007 Los Angeles California
Local Institution - 0011 Grand Rapids Michigan
Local Institution - 0004 Sioux Falls South Dakota
Local Institution - 0013 San Antonio Texas
Local Institution - 0021 Darlinghurst New South Wales
Local Institution - 0019 Elizabeth Vale South Australia
Local Institution - 0017 Toronto Ontario
Local Institution - 0016 Montreal Quebec
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06544655 on ClinicalTrials.gov ↗ ← All trials in Australia